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FDA 510(k)

EasyClip Xpress

K-Number: K162321 · 2017-02-10

ApplicantRestore Surgical, LLC Dba Instratek
Decision Date2017-02-10
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EasyClip Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K162321. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyClip Xpress?

EasyClip Xpress is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Restore Surgical, LLC Dba Instratek. The 510(k) number is K162321.

When did EasyClip Xpress receive FDA 510(k) clearance?

EasyClip Xpress received FDA 510(k) clearance on 2017-02-10, under 510(k) number K162321.

Who is the listed applicant for EasyClip Xpress?

The FDA 510(k) record lists Restore Surgical, LLC Dba Instratek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyClip Xpress?

The FDA product code for EasyClip Xpress is JDR.

Other records listing Restore Surgical, LLC Dba Instratek as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161778ToeTac™ 10° Hammertoe Fixation System

Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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